Study to Evaluate Safety and Effectiveness of the Adaptive Tip Catheter for Treating Acute Ischemic Stroke with Mechanical Thrombectomy

What this Trial Is About

The trial investigates the use of the Adaptive Tip Catheter ATC as a first-line direct aspiration device for mechanical thrombectomy in patients experiencing an acute ischemic stroke in the anterior circulation. It aims to evaluate both the safety and effectiveness of this catheter in treating this serious condition. Participants will undergo mechanical thrombectomy using the ATC alone, attempting to remove the clot within the first three passes or until successful reperfusion is achieved if fewer passes are needed. After the procedure, patients will be monitored for 90 days to assess recovery and outcomes related to stroke treatment. During the study, researchers will assess reperfusion success through imaging, focusing on the third pass and overall procedure results. They will also monitor clinical outcomes such as functional independence measured by the Modified Rankin Scale, vessel damage, mortality, and any symptomatic brain bleeding. Follow-up evaluations occur up to 90 days post-procedure to gather these safety and effectiveness data.

A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke